consent form version update – Clinical Research Made Simple

Re-Consent After Protocol Amendments or Safety Updates in Clinical Trials

June 27, 2025

Re-Consent After Protocol Amendments or Safety Updates in Clinical Trials How to Re-Consent Clinical Trial Participants After Protocol Amendments or Safety Updates Clinical trials are dynamic, and changes in protocol or newly identified safety risks often require informing participants and obtaining renewed consent. This process, known as re-consent, is essential for maintaining ethical integrity, ensuring…

Informed Consent and Ethics Committees, Re-Consent Procedures

Re-Consent in Long-Term Extension Studies: Best Practices for Ethical Compliance

June 26, 2025

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Re-Consent in Long-Term Extension Studies: Best Practices for Ethical Compliance Managing Re-Consent in Long-Term Extension Clinical Trials As clinical research progresses beyond the primary endpoint, many trials transition into long-term extension (LTE) phases. These studies allow continued access to investigational therapies and further evaluation of long-term safety and efficacy. However, transitioning participants into LTE studies…

Informed Consent and Ethics Committees, Re-Consent Procedures